Economic Impact of Coverage Expansion for Non-invasive Prenatal Testing Through a Performance-Based Risk-Sharing Agreement

Taryn A G Quinlan; Brock Schroeder; Sue Kwon; Jane F Barlow; Michael S Sherman; Heather D Anderson; Garth Wright; R Brett McQueen

doi:10.1007/s41669-021-00261-y

Economic Impact of Coverage Expansion for Non-invasive Prenatal Testing Through a Performance-Based Risk-Sharing Agreement

Pharmacoecon Open. 2021 Sep;5(3):449-458. doi: 10.1007/s41669-021-00261-y. Epub 2021 Mar 10.

Authors

Taryn A G Quinlan¹, Brock Schroeder², Sue Kwon³, Jane F Barlow⁴, Michael S Sherman^{5

6}, Heather D Anderson³, Garth Wright³, R Brett McQueen^{7

8}

Affiliations

¹ Department of Health Systems, Management and Policy, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
² Illumina, Inc., San Diego, CA, USA.
³ Department of Clinical Pharmacy, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
⁴ Real Endpoints, LLC, Florham Park, NJ, USA.
⁵ Harvard Pilgrim Health Care, Wellesley, MA, USA.
⁶ Department of Population Medicine, Harvard Medical School, Boston, MA, USA.
⁷ Department of Clinical Pharmacy, University of Colorado Anschutz Medical Campus, Aurora, CO, USA. Robert.mcqueen@cuanschutz.edu.
⁸ Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Mail Stop C238, 12850 E. Montview Blvd, Aurora, CO, 80045, USA. Robert.mcqueen@cuanschutz.edu.

Abstract

Background: Harvard Pilgrim Health Care expanded coverage for non-invasive prenatal testing (NIPT) to include all pregnant, single-gestation women aged < 35 years, through a performance-based risk-sharing (PBRS) agreement with Illumina to offset costs from coverage expansion. NIPT analyzes cell-free DNA fragments from a maternal blood sample to screen for fetal aneuploidies and is considered a more accurate screening method than conventional serum biochemical screening and nuchal translucency ultrasound-based approaches.

Objective: This study assessed the impact of NIPT coverage expansion on prenatal screening strategies and payer expenditures.

Methods: This was a real-world comparison of utilization and expenditures of prenatal screening and diagnostic testing in pregnant women aged < 35 years pre- (1 March 2016-28 February 2018) and post- (1 March 2018-30 September 2019) coverage expansion. Incidence rate ratios (IRRs) with 95% confidence intervals (CIs) were estimated to compare changes in utilization of conventional and NIPT-based prenatal screening methods. Change in per member per month (PMPM) expenditures in $US year 2020 were assessed post-coverage expansion using a budget impact model.

Results: A total of 5041 and 4109 distinct pregnancies were identified in pre- and post-coverage expansion periods, respectively. Mean ± standard deviation maternal age was consistent between pre- and post-coverage expansion periods (30.35 ± 3.35 and 30.33 ± 3.28, respectively). Screening orders for conventional methods decreased, with an adjusted IRR in the post-expansion period of 0.87 (95% CI 0.85-0.90) times the rate in the pre-expansion period; orders for NIPT increased, with an adjusted IRR in the post-expansion period of 1.41 (95% CI 1.32-1.51) times the rate in the pre-expansion period. Invasive diagnostic testing was low at baseline (1.0%) and did not change post-coverage expansion. The change in PMPM is estimated at $US0.026 post-coverage expansion.

Conclusion: The PBRS agreement to expand NIPT coverage for women aged < 35 years was associated with an increase in NIPT utilization, decreases in conventional screening methods, and a modest increase in PMPM expenditures.